Acute migraine therapy with external trigeminal neurostimulation (ACME): A randomized controlled trial
Acute migraine therapy with external trigeminal neurostimulation (ACME): A randomized controlled trial
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DOI：
10.1177/0333102418811573
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发表时间：
2019-01-01
期刊：
影响因子：
4.9
通讯作者：
Schoenen, Jean
中科院分区：
文献类型：
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作者：
Chou, Denise E.;Yugrakh, Marianna Shnayderman;Schoenen, Jean
目的通过假手术对照试验，评价三叉神经外刺激对有先兆和无先兆偏头痛发作急性疼痛的疗效和安全性。方法这是一项双盲、随机、假对照的研究，在美国的三个头痛中心进行。在现场招募正在经历有或无先兆的急性偏头痛发作的成年患者，并以1：1随机分配接受1小时的真三叉神经外刺激治疗或假三叉神经外刺激治疗（CENTURY Technology）。使用视觉模拟量表对疼痛强度进行评分（0 =无疼痛至10 =最大疼痛）。主要结局指标是1小时时疼痛强度与基线相比的平均变化。结果在2016年2月1日至2017年3月31日期间，共筛选了109名参与者。其中，106例患者被随机化并纳入意向治疗分析（verum：n = 52; sham：n = 54）。verum组的主要结局指标比假手术组显著降低：-3.46 +/- 2.32 vs-1.78 +/- 1.89（p < 0.0001），或-59% vs-30%（p < 0.0001）。关于偏头痛亚组，对于“无先兆偏头痛”发作，verum和假手术之间的疼痛减轻有显著差异：verum组1小时时的平均视觉模拟量表减少为-3.3 +/- 2.4，假手术组为-1.7 +/- 1.9（p = 0.0006）。对于“有先兆的偏头痛”发作，verum组的疼痛减轻程度在数值上大于sham组，但并未达到显著性：verum组1小时时的平均视觉模拟量表减轻程度为-4.3 +/- 1.8，而假手术组为-2.6 +/- 1.9（p = 0.060）。未报告严重不良事件，verum组发生5起轻微不良事件。结论三叉神经外刺激治疗1 h可显著缓解头痛，且耐受性良好，是一种安全有效的偏头痛急性治疗方法。研究方案ClinicalTrials.gov标识符：NCT 02590939。
Objective To assess the safety and efficacy of external trigeminal nerve stimulation for acute pain relief during migraine attacks with or without aura via a sham-controlled trial. Methods This was a double-blind, randomized, sham-controlled study conducted across three headache centers in the United States. Adult patients who were experiencing an acute migraine attack with or without aura were recruited on site and randomly assigned 1:1 to receive either verum or sham external trigeminal nerve stimulation treatment (CEFALY Technology) for 1 hour. Pain intensity was scored using a visual analogue scale (0 = no pain to 10 = maximum pain). The primary outcome measure was the mean change in pain intensity at 1 hour compared to baseline. Results A total of 109 participants were screened between February 1, 2016 and March 31, 2017. Of these, 106 patients were randomized and included in the intention-to-treat analysis (verum: n = 52; sham: n = 54). The primary outcome measure was significantly more reduced in the verum group than in the sham group: -3.46 +/- 2.32 versus -1.78 +/- 1.89 (p < 0.0001), or -59% versus -30% (p < 0.0001). With regards to migraine subgroups, there was a significant difference in pain reduction between verum and sham for 'migraine without aura' attacks: mean visual analogue scale reduction at 1 hour was -3.3 +/- 2.4 for the verum group versus -1.7 +/- 1.9 for the sham group (p = 0.0006). For 'migraine with aura' attacks, pain reduction was numerically greater for verum versus sham, but did not reach significance: mean visual analogue scale reduction at 1 hour was -4.3 +/- 1.8 for the verum group versus -2.6 +/- 1.9 for the sham group (p = 0.060). No serious adverse events were reported and five minor adverse events occurred in the verum group. Conclusion One-hour treatment with external trigeminal nerve stimulation resulted in significant headache pain relief compared to sham stimulation and was well tolerated, suggesting it may be a safe and effective acute treatment for migraine attacks. Study protocol ClinicalTrials.gov Identifier: NCT02590939.